The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Uni-shunt(tm) With Elliptical Reservoir Kit.
| Device ID | K892215 |
| 510k Number | K892215 |
| Device Name: | UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Thomas J Courage |
| Correspondent | Thomas J Courage Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-08-21 |